PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

This study is ongoing, but not recruiting participants.

First Received: September 24, 2007 Last Updated: February 17, 2009 History of Changes

Sponsored by:	Abiomed Inc.
Information provided by:	Abiomed Inc.
ClinicalTrials.gov Identifier:	NCT00534859

Purpose

The objective of this feasibility study is to demonstrated that the device is safe and potentially efficacious for use in patients underging high risk Percutaneous Coronary Interventions(PCI).Patients will be enrolled if they meet inclusion & exclusion criteria.

Condition	Intervention	Phase
Patients Undergoing High Risk PCI.	Device: High Risk PCI	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

Further study details as provided by Abiomed Inc.:

Estimated Enrollment:	20
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2007

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Signed Informed Consent
Non emergent PCI of at least one de novo or restenostic lesion in a native coronary vessel or bypass graft
EF <35%

Exclusion Criteria:

ST Myocardial Infarction
Cardiac Arrest
Cardiogenic shock
Thrombus Lt Ventricl

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00534859

Locations

United States, California
Scripps
La Jolla, California, United States, 92037
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Massachusetts
Brigham & Womens
Boston, Massachusetts, United States, 02115
Massach General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
William Beaumont
Royal Oak, Michigan, United States, 48073
United States, New York
Columbia Presbyterian Hospital
New York,, New York, United States, 10032
United States, Texas
Texas Heart
Houston, Texas, United States, 777030
Netherlands, Netherland
Academic Medical Center
Amsterdam, Netherland, Netherlands

Sponsors and Collaborators

Abiomed Inc.

Investigators

Principal Investigator:

William O'Neill, M.D.

Not affilicated with Abiomed

More Information

No publications provided

Responsible Party:	Abiomed Inc
Study ID Numbers:	G050017
Study First Received:	September 24, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00534859 History of Changes
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 07, 2009